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Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629421
First Posted: March 6, 2008
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
February 26, 2008
March 6, 2008
August 22, 2017
January 1, 2001
December 31, 2016   (Final data collection date for primary outcome measure)
development of hepatocellular carcinoma [ Time Frame: during observation ]
nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy
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Complete list of historical versions of study NCT00629421 on ClinicalTrials.gov Archive Site
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Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study
Although serum alpha-fetoprotein level and abdominal sonography are the main methods to screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods used are not completely well-defined. This study aims to assess the better timing and methods for prospectively screening HCC in patients with cirrhosis
Well-diagnosed consecutive patients with cirrhosis were enrolled through a designed questionnaire to obtain basic information about gender, age, etiology of cirrhosis, conventional liver function tests, serum AFP level, education level, substance use including smoking, alcohol drinking, betel quid chewing, history of familial HCC, etc. Then the patients was followed by periodic abdominal sonography examination and determination of AFP and liver function. If AFP elevated or liver nodule appears, effort to diagnose HCC will be performed.If HCC was performed, the survival will be followed-up. As anti-viral therapy was found to decrease risk for HCC, patients with those therapy will be excluded.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Well-dignosed patients with cirrhosis
  • Cirrhosis
  • Hepatocellular Carcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
December 31, 2016
December 31, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Image diagnosis or biochemical diagnosis or presence of portal hypertension

Exclusion Criteria:

  • Presence of hepatocellular carcinoma
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00629421
KMUH-IRB-960012
No
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Jung-Fa,Tsai, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: Jung-Fa Tsai, M.D., Ph.D. Kaohsiung Medical University
Kaohsiung Medical University Chung-Ho Memorial Hospital
August 2017